Can a skin ointment calm two stubborn redness conditions?
NCT ID NCT06013371
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This phase 2 trial tests whether a once-daily topical ointment called PF-07038124 can ease moderate-to-severe seborrheic dermatitis and papulopustular rosacea. Adults with either condition will apply the ointment or a placebo for 8 weeks, with follow-up visits to check skin improvements and safety. The goal is to see if blocking PDE4 in the skin reduces redness, scaling, and inflammatory bumps.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PF-07038124, a topical ointment that blocks PDE4 to reduce skin inflammation
- What this could lead to
- If successful, this could offer a new non-steroid topical treatment option for two common, chronic skin conditions that cause redness, scaling, and bumps.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not hold up in larger studies. The ointment may cause skin irritation or other side effects, and it may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
32 people
The number who actually took part.
- Started
-
Jul 2023
- Finished
-
Feb 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female subjects ≥ 18 years of age at the time of signing the informed consent document. * Subject is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures. * Subject is able to adhere to the study visit schedule and other protocol requirements. * Diagnosis of SD and baseline IGA ≥ 3 with facial involvement * OR * Diagnosis of PPR, baseline IGA ≥ 3, and baseline inflammatory lesion count ≥ 12 * Subject agrees to discontinue all treatments for SD and PPR from screening through study completion aside from the study drug * Subject is judged to be in otherwise good overall health as judged by the investigator, based on medical history, physical examination, and laboratory testing. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions). * Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on the study drug and for at least 90 days after the last application of the study drug, male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below: * Option 1: Any one of the following highly effective contraceptive methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy. * OR * Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural \[animal\] membrane \[for example, polyurethane\]); PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide. The female subject's chosen form of contraception must be effective by the time the female subject is enrolled into the study. Exclusion Criteria: The presence of any of the following will exclude a subject from enrollment: * Subjects with other skin diseases that would interfere with the study assessment in the opinion of the investigator. * Active bacterial, fungal, or viral skin infection within 2 weeks from study initiation. * Subject has clinically significant (as determined by the investigator) renal, hepatic, hematologic, intestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric, immunologic, or other major uncontrolled diseases (e.g., malignancy, TB, thromboembolic events) that will affect the health of the subject during the study, or interfere with the interpretation of study results. * Subject has previously received treatment with oral or topical PDE4 inhibitors. * Current other topical treatments (e.g., topical corticosteroids, topical calcineurin inhibitors, topical JAK inhibitors, topical metronidazole, topical minocycline, topical ivermectin, topical azelaic acid, topical brimonidine, topical oxymetazalone, topical antihistamines, topical antibacterials) within 2 weeks of baseline. * Use of systemic non-biologic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus, oral JAK inhibitors within 4 weeks of study initiation. * Use of systemic biologic immunosuppressive medications, including, but not limited to inhibitors of IL-17, IL-12/23, or IL-23, TNF inhibitors, dupilumab, and abatacept within 12 weeks of baseline. * History of adverse systemic or allergic reactions to any component of the study drug. * Current participation in any other study with a biologic investigational medication within 6 months of baseline, or non-biologic investigational medication within 12 weeks of baseline. * Subject who is pregnant or breast feeding. * SD or PPR Baseline IGA \< 3; PPR inflammatory lesion count \<12; SD with no facial involvement. * Active hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or positive HIV serology at the time of screening for subjects determined by the investigators to be at high-risk for this disease.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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